Cardiovascular disease, hypertension (elevated blood pressure) Circulatory System Hypertensive diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men or women aged 35 years or older 2. Seated clinic systolic BP =130 mmHg or previously diagnosed with hypertension and currently taking prescription medication to lower BP 3. Wrist circumference 16-19 cm (i.e. suitable for HeartGuide watch BP monitor) 4. Willing and able to provide informed consent
Exclusion criteria
Exclusion criteria: 1. People who are unable or unwilling to provide informed consent 2. Women who are pregnant 3. Participants with a wrist circumference >19 cm (unsuitable for the HeartGuide wrist monitor) 4. Participants with an upper arm circumference >42.0 cm (unreliable cuff-based BP measurement) 5. Participants unwilling or unable to undergo a cardiac MRI scan 6. Participants unwilling or unable to undertake a minimum of 3 consecutive weekdays of wrist blood pressure monitoring (using the HeartGuide watch BP monitor) 7. Participants unwilling or unable to undertake a continuous 24-hour period of ambulatory blood pressure monitoring 8. Participants with sustained atrial fibrillation or other significant arrhythmia (makes BP measurement unreliable) 9. People currently enrolled in another on-going clinical trial or study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. “Out of office” systolic BP, measured using the HeartGuide watch BP monitor at Baseline – Visit 1 2. Left ventricular mass index (LVMI) measured by cMRI at Baseline – Visit 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean BP indices measured by the HeartGuide watch BP monitor at baseline – Visit 1 2. Mean BP indices measured by 24-hour ambulatory BP monitoring (ABPM) at baseline – Visit 2 3. Mean BP indices measured by seated clinic BP at baseline – Visit 1 4. Heart wall thickness measured as left ventricular mass index (LVMI) or unindexed left ventricular (LV) mass by cardiac MRI (cMRI) at baseline – Visit 3 5. Arterial stiffness measured using the Cardio-Ankle Vascular Index (CAVI) at baseline – Visit 1 6. ECG voltage criteria for LV mass measured at baseline – Visit 1 7. cMRI parameters including LVMI/unindexed LV mass, cardiac volumes and indices of vascular structure/function at baseline – Visit 3 | — |
Countries
England, United Kingdom